Fordham University’s Dr. Celia Fisher Discusses What the Revised Common Rule Means for Informed Consent in Medical Ethics Advisor

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The Federal Policy for the Protection of Human Subjects, or the Common Rule was revised earlier this year and is set to be effective on January 19th, 2018. The Common Rule was created in 1991 to “better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” Departments and agencies including, but not limited to, the Department of Homeland Security, the Department of Health and Human Services and the National Science Foundation made these revisions in an effort to “modernize, simplify, and enhance the current system of oversight.”

In this year’s October issue of Medical Ethics Advisor, Dr. Celia Fisher, Director of Fordham University’s Center for Ethics Education and HIV and Drug Abuse Prevention Research Ethics Training Institute, discusses two significant ways the revised Common Rule will change informed consent practices in research, and critical ethical questions to consider about these changes.

According to Dr. Fisher, the first change, stating that investigators are permitted to obtain broad consent from participants for future use of identifiable biospecimens by the original investigator or other investigators, “increases the ability of scientists to combine large data sets to explore important medical questions.” However, she says, “it is unclear whether hacking or the use of the identifiable information…will pose a social or economic risk to participants.” Dr. Fisher continues that it could be additionally problematic if “identifiable data is used to inform policies that promote medical discrimination of already vulnerable groups” without the research participants understanding how their data will be used in the future.

The second revision of the Common Rule that will impact informed consent practices states that investigators are required to give prospective participants a brief summary of “key points” that a reasonable person would want to know to make an informed choice. Dr. Fisher notes that this revision “can be an advantage over the current risk-averse legal language in informed consent materials,” but the revision does not state who will be deciding what the key points are which could be potentially problematic considering participants, investigators and IRB members may have different ideas of what “important information” is.

To read the full article and October’s Issue of Medical Ethics Advisor, please visit their website here. To subscribe to the journal, please visit AHC Media.

Dr. Celia Fisher is the Mary Ward Doty University Chair in Ethics at Fordham University, a professor of Psychology and the director of Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute. In addition to chairing the 2002 revision of the American Psychological Association’s Ethics Code, Fisher’s Decoding the Ethics Code: A Practical Guide for Psychologists is now in its fourth edition from Sage Publications.  Please visit her webpage for more information about her work, as well as the Fordham University Center for Ethics Education Research page.

NIH’s New Definition of “Children” Finally Gets it Right: A Welcome Change for Children’s Health Equity

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By Celia B. Fisher, Ph.D.

Under current federal research regulations, a “child” is defined as an individual younger than 21 years of age – a policy that has produced inequities in health research for youth younger than 18 years of age.

Beginning January 25th, 2016, that will change: the age of a child will be defined as an individual less than 18 years old. This is a welcome change that can begin to address the urgent need for age- and population-targeted research to avoid the use of treatments tested in young adult populations that may be unsuited for adolescents and children.

Continue reading “NIH’s New Definition of “Children” Finally Gets it Right: A Welcome Change for Children’s Health Equity”

Minimal risk and minimal experience: Can researchers competently navigate OHRP’s new risk categories?

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By: Celia B. Fisher, Ph.D.

The U.S. Department of Health and Human Services has announced proposed revisions to modernize federal regulations governing the protection of research participants’ rights and welfare. The newly proposed regulations have many positive features that will improve the informed consent process through transparency and stricter requirements to protect participant privacy and enhance informed consent.

Continue reading “Minimal risk and minimal experience: Can researchers competently navigate OHRP’s new risk categories?”

Issues of Research Ethics in the Facebook ‘Mood Manipulation’ Study: The Importance of Multiple Perspectives

 

By: Michelle Broaddus, Ph.D.

A new study using Facebook data to study “emotional contagion,” and the ensuing backlash of its publication offers the opportunity to examine several ethical principles in research. One of the pillars of ethically conducted research is balancing the risks to the individual participants against the potential benefits to society or scientific knowledge. While the study’s effects were quite small, the authors argue that “given the massive scale of social networks such as Facebook, even small effects can have large aggregated consequences.” However, participants were not allowed to give informed consent, which constitutes a risk of the research and the major source of the backlash.

Continue reading “Issues of Research Ethics in the Facebook ‘Mood Manipulation’ Study: The Importance of Multiple Perspectives”

Issues of Research Ethics in the Facebook ‘Mood Manipulation’ Study: The Importance of Multiple Perspectives (full text)

 

By: Michelle Broaddus, Ph.D.

A recent paper published in the Proceedings of the National Academy of Sciences describes a mood manipulation experiment conducted by Facebook scientists during one week in 2012 that suggests evidence of “emotional contagion,” or the spread of positive and negative affect between people. The backlash to this publication has been significant. As two examples, Slate.com published a piece entitled “Facebook’s Unethical Experiment: It intentionally manipulated users’ emotions without their knowledge” and The Atlantic’s piece, “Even the Editor of Facebook’s Mood Study Thought It Was Creepy.”

Continue reading “Issues of Research Ethics in the Facebook ‘Mood Manipulation’ Study: The Importance of Multiple Perspectives (full text)”

What can you do with a degree in ethics? Video of Careers in Ethics Panel now available.

Dr. Adam L. Fried with the other members of the Careers in Ethics Panel
Dr. Adam L. Fried with the other members of the Careers in Ethics Panel. Click on photo to watch a video of the panel discussion.

Because of the interdisciplinary nature of ethics, it is relevant and necessary in everything from medicine, business and journalism, to psychology, law, and environmental studies. Ethics is interesting to study, but what are the career options in the field?

Continue reading “What can you do with a degree in ethics? Video of Careers in Ethics Panel now available.”

Improved Regulations to Protect Human Research Subjects Would Reduce Burden on IRBs While Better Protecting Study Participants

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Proposed updates to federal regulations that protect human research subjects need additional clarification when applied to the social and behavioral sciences, says a new report from the National Research Council.  Fordham University Center for Ethics Education Director Dr. Celia B. Fisher was a member of the committee and an author of the report.

Continue reading “Improved Regulations to Protect Human Research Subjects Would Reduce Burden on IRBs While Better Protecting Study Participants”